Pain Management Following Musculoskeletal Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stephen T. Wegener, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01689675
First received: September 7, 2012
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

Musculoskeletal sprain/strain injuries and disorders (MSID) have a major impact on health, quality of life and societal productivity. Early intervention for pain following acute MSIDs may prevent secondary complications of chronic pain, disability, reduced quality of life or lost productivity. The investigators goal is to evaluate the efficacy of a computer-based self-management intervention for reducing pain and improving function in persons treated in on-site physical rehabilitation centers.

The specific aims are:1) evaluate the efficacy of a computer-based self-management intervention in reducing pain and self-efficacy and function in high risk MSID patients; 2) determine long term impact during a six month follow-up period; and 3) determine whether reductions of pain and improved function translate into reductions in lost work time days away from work, restricted work days, worker's compensation costs and re-injury rates during the 6 month follow-up.

Persons with sprain/strain injuries at risk for poor pain control will randomized to either: 1) control condition - standard care in the rehabilitation center plus computer exposure or 2) standard care plus computer-based self-management pain intervention. Assessment will be at baseline, treatment completion, 3 and 6 months. The primary outcome measures are self-efficacy, pain and physical/psychosocial functioning and secondary outcome measures are days away from work, restricted work days worker's compensation costs and re-injury rates. The investigation will also provide unique and valuable information regarding patients acceptance and use of computer-based interventions following acute injury. By establishing the utility and efficacy of computer-based pain management interventions for MSID the investigators have the potential to improve the health and quality of life of persons with injuries, improve productivity and develop new methods for health care delivery.


Condition Intervention
Musculoskeletal Strain
Musculoskeletal Sprain
Injury of Musculoskeletal System
Behavioral: Computer based pain management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Pain Management Following Musculoskeletal Injury

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 month followup ] [ Designated as safety issue: No ]
    Pain will be measured using the Brief Pain Inventory, which includes 4 pain items assessing current, worst, least, and average pain (0-no pain to 10-as bad as you can imagine) during the past week. This scale has excellent reliability and validity in a wide variety of acute and chronically painful conditions. In addition to measuring pain severity, 10 items measure pain-related interference in daily activities (0-does not interfere to 10-completely interferes) which also shows excellent reliability and validity in a wide variety of acute and chronically painful conditions.

  • Physical and Psychosocial Function [ Time Frame: 3 month followup ] [ Designated as safety issue: No ]
    The SF-12 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-12 includes items that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. A total score and two subscales scores are calculated -physical function and psychosocial function. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer, self-report, or by telephone.


Secondary Outcome Measures:
  • Work Productivity [ Time Frame: 3 month followup ] [ Designated as safety issue: No ]
    Work productivity will be measured by the number of days away from work, restricted work days, and Worker's compensation costs related to this incident of care. Due to the lost productivity and worker compensation cost associated with MSID, it is critical to include these measures in the outcome analyses 10. In addition, the number of re-injuries that occur following treatment will also be included as an outcome measure. These data are available through contacting Worker's Compensation intermediary. We have experience accessing, manipulating and analyzing these data for previous program evaluation cost benefit analyses.


Other Outcome Measures:
  • Catastrophizing [ Time Frame: 3 month followup ] [ Designated as safety issue: No ]
    The Pain Catastrophizing Scale will be used to measure catastrophic thinking related to pain. Respondents rate the frequency with which they experience 13 different thoughts and feelings related to pain. The scale has been shown to be reliable (alpha =.87) and has been associated with pain levels, self-reported disability and employment status.

  • Self-Efficacy [ Time Frame: 3 month followup ] [ Designated as safety issue: No ]
    There is evidence that enhancement of perceived self- efficacy may mediate pain control and improved psychosocial functioning in persons who participate in self-management intervention. Self-efficacy for pain management will be measured using the Pain Self-Efficacy scale which includes subscales that measure self-efficacy for pain management, self-efficacy for coping with symptoms, and self-efficacy for physical function.

  • Fear-avoidance beliefs [ Time Frame: 3 month followup ] [ Designated as safety issue: No ]
    This variable will be measured with 2 questionnaires: 1) The Tampa Scale of Kinesiophobia (TSK), which has been shown to be a relevant measure of fear of movement/activity; 2) A modified form of the Fear-Avoidance Behavior Questionnaire that contains four items from the physical activity scales. These measures have both been associated with long term pain and work disability in acutely injured individuals.

  • Utility and Use of Intervention Materials [ Time Frame: 4 weeks after starting treatment ] [ Designated as safety issue: No ]
    The use of computers for delivery of the intervention allows for ongoing monitoring of intervention activity materials. Quantitative metrics will be collected as part of the intervention including sessions attended, the amount of the program completed in each session, and utilization of Support Services (time on bulletin board and number of postings). Utilization of the website containing the intervention, Support Service and assessment materials will be evaluated for (1) the effectiveness with which users can accomplish tasks; (2) the speed with which users can find the information they are seeking and navigate through the elements of the prototype session; (3) the paths users take to complete a task; and 4) users' satisfaction level using the interactive tools. Qualitative data to be collected includes: user comments, concerns, frustrations, and suggestions.


Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computer based pain management
The computer-based self-management program (CBSM) intervention will be administered over 8 sessions during the average 4 week period patients are receiving their standard on-site rehabilitation care. Patients will come to the center to receive their standard care and then interact with the computer for the 25-30 minute CBSM intervention. The primary goals of treatment include developing skills for managing acute injury and related pain including: reducing fear avoidance beliefs and catastrophizing, improving mood, increasing perceptions of control and self-efficacy, maintaining activity and reducing pain. Skills are presented and modeled by computer-based video during sessions, audio will be used to explain models and teach skills such as relaxation training.
Behavioral: Computer based pain management
Active Comparator: Education control
The computer exposure will be administered over 8 sessions during the average 4-week period patients are receiving their standard on-site rehabilitation care. Patients will come to the center to receive their standard care and then interact with the computer for the 25-30 minute control condition. The primary goal of this condition is to provide a control for computer exposure. Briefly, the first session will concentrate on establishing the patient's ability to interact with the computer. The materials will provide general education regarding the injury and methods for preventing re-injury. This condition will not provide teaching and practice of specific pain management and coping management skills. This control computer education activity will equalize the computer exposure of the two groups and the duration of time devoted to injury care.
Behavioral: Computer based pain management

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. age 18 years or older
  2. Musculoskeletal sprain/strain injury
  3. pain level greater or equal to 5
  4. English speaking

Exclusion Criteria:

  1. Age < 18
  2. non-English speaking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01689675

Contacts
Contact: Patricia R Kirkhart, BA 410-502-4453 pkirkha1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Patricia R Kirkhart, BA    410-502-4453    pkirkha1@jhmi.edu   
Principal Investigator: Stephen T Wegener, PhD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kristin Archer, PhD, PT    615-322-2732    kristin.archer@vanderbilit.edu   
Contact: Kenya Stringfellow    615-936-1877    kenya.robinson@vanderbilt.edu   
Principal Investigator: Kristin Archer, Phd, PT         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Stephen T Wegener, PhD Johns Hopkins University
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen T. Wegener, Associate Professor, Director, Division of Rehabilitation Psychology and Neuropsychology, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01689675     History of Changes
Other Study ID Numbers: NA_00049927, 1R01AR054009-01A1
Study First Received: September 7, 2012
Last Updated: September 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
musculoskeletal
pain
pain management
computer based intervention

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on August 25, 2014